NCT01412619

Brief Summary

Patients after cardiac surgical operations often exhibit neuropsychological complications. In particular, the post-operative delirium is associated with a significantly increased morbidity and mortality. Intracerebral microembolization in addition to inadequate cerebral perfusion during surgery was verified as the main cause of this. The aim of the study is to demonstrate a correlation between intraoperative low measured cerebral oxygen levels and a loss neurological outcome, especially the development of postoperative delirium, using non-invasive cerebral oximetry (RSO2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

3 years

First QC Date

August 2, 2011

Last Update Submit

December 24, 2011

Conditions

Neurological Outcome

Keywords

Neurological OutcomeIntraoperative intracerebral Oxygen levelMean arterial blood pressureCentral venous blood pressureCardiac outputSerum LactateVenous oxygen saturationFluid balance

Outcome Measures

Primary Outcomes (1)

  • CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Questionnaire

    CAM-ICU Quesionnaire is used to assess the patient´s ability of postoperative orientation, to detect and treat changes between preoperative and postoperative questionnaires and therefore a potential postoperative delirium earliest possible.

    Changes between 6 - 48 hours before surgery and 12 hours after surgery

Secondary Outcomes (6)

  • MIF (Macrophage Migration Inhibitory Factor)

    Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.

  • Cytokine IL-6

    Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.

  • Cytokine IL-10

    Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.

  • Procalcitonin (PCT)

    Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.

  • S-100 Protein

    Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 100 adult patients (male and female), capable of consenting, undergoing elective cardiac surgery at heart-lung-machine

You may qualify if:

  • Age of 18 years or older
  • Elective cardiac surgery at heart-lung-machine

You may not qualify if:

  • Pregnancy or lactation period
  • Patients not capable of consenting
  • Emergency surgery
  • Patients under 18 years
  • Known depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

Related Publications (1)

  • Stoppe C, Fries M, Rossaint R, Grieb G, Coburn M, Simons D, Brucken D, Bernhagen J, Pallua N, Rex S. Blood levels of macrophage migration inhibitory factor after successful resuscitation from cardiac arrest. PLoS One. 2012;7(4):e33512. doi: 10.1371/journal.pone.0033512. Epub 2012 Apr 10.

    PMID: 22506003DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cytokine IL-6 Cytokine IL-10 Procalcitonin (PCT) S-100-Protein

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 9, 2011

Study Start

December 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations

DE(1)